Posts Tagged:PDUFA

The Food and Drug Administration (FDA) regulates 25% of the U.S. economy. For fiscal year 2016, the FDA’s budget is $4.9 billion, with $2.2 billion (or 45%) generated from user fees, payments collected by the FDA from companies submitting new drug, biologics and medical device applications for review. They were authorized under the Prescription Drug User Fee Act (PDUFA, 1992) and Medical Devices User Fee Act…